Device Classification Name |
system, x-ray, tomography, computed
|
510(k) Number |
K120910 |
Device Name |
CARDIQ XPRESS 2.0 WITH SNAPSHOT FREEZE OPTION CARDIQ XPRESS 2.0 REVEAL |
Applicant |
GE MEDICAL SYSTEMS SCS |
283, RUE DE LA MINIERE |
BUC,
FR
78530
|
|
Applicant Contact |
STEPHEN SLAVENS |
Correspondent |
GE MEDICAL SYSTEMS SCS |
283, RUE DE LA MINIERE |
BUC,
FR
78530
|
|
Correspondent Contact |
STEPHEN SLAVENS |
Regulation Number | 892.1750
|
Classification Product Code |
|
Date Received | 03/26/2012 |
Decision Date | 06/18/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|